MenstruationNCT05553600

Tampon Design Validation Study

A study testing Tampon BR, Tampon CR and Tampon BS in people with Menstruation, run by Kimberly-Clark Corporation at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met. Read more about this study

Who is it for?: Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menstruation
What is being tested?: Tampon BR, Tampon CR and Tampon BS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 732 participants
Where: 9 sitesUnited States
Study dates: 21 Oct 2022to 5 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Willing and able to read and provide written informed consent.
Female in good general health, age 18-49 (inclusive).
History of regular menstrual cycles during the previous 3months lasting approximately 21-35 days, including at least 4 days of menstruation, and expecting to menstruate during the study period.
History of use of applicator tampons without discomfort.
Normally use at least 6 tampons for protection during menstruation.
Normally uses regular, super, and/or super plus absorbency tampons for menstrual protection.
Agrees to the conduct of all study procedures, including gynecological exams (if applicable), and agrees to follow all study instructions and return for scheduled appointments.
Has used an acceptable form of birth control for at least one month prior to enrollment and for the duration of the study.

Who cannot join

Pregnant, lactating or is trying to become pregnant.
Less than six (6) weeks post-partum.
Has a menstrual abnormality (such as oligomenorrhea or amenorrhea).
Has a known allergy or sensitivity to components of the investigational products, including rayon.
Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Velocity Clinical Research
Anderson, South Carolina, 29621
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Velocity Clinical Research
Boise, Idaho, 83642
Signature Gyn Services
Fort Worth, Texas, 76104
Velocity Clinical Research
Greenville, South Carolina, 29615
TMC Life Research, Inc.
Houston, Texas, 77054
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115
Princeton Consumer Research
Raritan, New Jersey, 08869
Del Sol Research Management, LLC
Tucson, Arizona, 85715

Other trials in United States

About this study

Official title: An Open-Label Clinical Validation Study of an Applicator Tampon

This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.

Conditions: Menstruation
Being tested: Tampon BR, Tampon CR, Tampon BS, Tampon CS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tampon BRDevice
Modified Regular Absorbency Tampons
Tampon CRDevice
Reference Regular Absorbency Tampons
Tampon BSDevice
Modified Super Absorbency Tampons
Tampon CSDevice
Reference Super Absorbency Tampons

Study groups in NCT05553600
Study group	Role	What they receive
Regular Absorbency	Other	Modified regular absorbency tampon versus regular absorbency reference tampon Receives: Device: Tampon BR; Device: Tampon CR
Super Absorbency	Other	Modified super absorbency tampon versus super absorbency reference tampon Receives: Device: Tampon BS; Device: Tampon CS

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage of Used Tampons That Have Elongated
The percentage of used tampons within each test code that have elongated >10mm. The denominator for the percentage calculation is based upon the number of used tampons returned within each test code.
Measured: At the end of 1 menstrual period (up to 10 days) for each intervention

Secondary outcomes (7)

Validation of Performance User Needs Based on Participant Diary Responses.
Percentage of participants reporting tampons performed as needed through diary responses. The following responses were solicited once at the end of the menstrual period.
Measured: At the end of 1 menstrual period (up to 10 days) for each intervention
Validation of Performance User Needs Based on Participant Diary Responses
Percentage of tampons performing as needed. The following diary responses were solicited after every tampon use.
Measured: At the end of 1 menstrual period (up to 10 days) for each intervention
Validation of Packaging/Labeling User Needs Based on Interview Responses
Proportion of participants able to locate key packaging/labeling information.
Measured: At baseline, prior to any interventions
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Number of subjects noted during pre- and post-use gynecological exams that had any lesions by anatomical location
Measured: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Pre-use Vaginal pH
Vaginal pH prior to tampon use.
Measured: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Post-use Vaginal pH
Vaginal pH after tampon use.
Measured: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Additional gynecological exam results prior to and following tampon use including: number of participants with suspected infections, other abnormal finding, and exam results that the investigators found clinically significant.
Measured: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 20225 May 2023

First posted23 Sep 2022
Study start21 Oct 2022
Primary completion5 May 2023
Study completion5 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MenstruationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 732 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05553600
Sponsor's protocol ID: AFC-21-001
Status last verified: Dec 2023
First submitted: 16 Sep 2022
Last updated: 17 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Menstruation trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Clinical Validation Study of an Applicator Tampon
ClinicalTrials.gov ID: NCT05553600
Acronym / sponsor ID: AFC-21-001
Conditions: Menstruation
Study type: Interventional
Recruitment status: Completed
Enrolment: 732 participants (actual)
Lead sponsor: Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
Study start: 21 Oct 2022 (actual)
Primary completion: 5 May 2023 (actual)
Study completion: 5 May 2023 (actual)
First posted: 23 Sep 2022 (actual)
Results: Posted 17 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Regular Absorbency	Other	Device: Tampon BR, Device: Tampon CRModified regular absorbency tampon versus regular absorbency reference tampon
Super Absorbency	Other	Device: Tampon BS, Device: Tampon CSModified super absorbency tampon versus super absorbency reference tampon

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Willing and able to read and provide written informed consent.
Female in good general health, age 18-49 (inclusive).
History of regular menstrual cycles during the previous 3months lasting approximately 21-35 days, including at least 4 days of menstruation, and expecting to menstruate during the study period.
History of use of applicator tampons without discomfort.
Normally use at least 6 tampons for protection during menstruation.

Key exclusion criteria (5 listed)

Pregnant, lactating or is trying to become pregnant.
Less than six (6) weeks post-partum.
Has a menstrual abnormality (such as oligomenorrhea or amenorrhea).
Has a known allergy or sensitivity to components of the investigational products, including rayon.
Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tampon BRModified Regular Absorbency Tampons	Device	Regular Absorbency
Tampon CRReference Regular Absorbency Tampons	Device	Regular Absorbency
Tampon BSModified Super Absorbency Tampons	Device	Super Absorbency
Tampon CSReference Super Absorbency Tampons	Device	Super Absorbency

Primary outcome

The Percentage of Used Tampons That Have Elongated
Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention
The percentage of used tampons within each test code that have elongated >10mm. The denominator for the percentage calculation is based upon the number of used tampons returned within each test code.

7 secondary outcomes

Validation of Performance User Needs Based on Participant Diary Responses.
Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention
Validation of Performance User Needs Based on Participant Diary Responses
Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention
Validation of Packaging/Labeling User Needs Based on Interview Responses
Time frame: At baseline, prior to any interventions
Number of Subjects That Had Any Lesions Noted During Gynecological Exam
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Pre-use Vaginal pH
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Post-use Vaginal pH
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention
Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results
Time frame: Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention

Results and safety

Results posted to the registry on 17 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Regular Absorbency: BR, Then CR	201	174
Regular Absorbency: CR, Then BR	203	173
Super Absorbency: BS, Then CS	166	145
Super Absorbency: CS, Then BS	162	140

Primary outcome: The Percentage of Used Tampons That Have Elongated

Time frame: At the end of 1 menstrual period (up to 10 days) for each intervention. Count of units. Unit: tampons

Measure	Tampon BR n = 264	Tampon CR n = 264	Tampon BS n = 223	Tampon CS n = 222
Value	2	75	4	48

Population analysed: All subjects who have no major protocol deviations and return at least 1 tampon that can be assessed for elongation.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 2 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tampon BR	1 of 323 (0.3%)	0 of 323 (0%)	0 of 323
Tampon CR	0 of 323 (0%)	0 of 323 (0%)	0 of 323
Tampon BS	0 of 263 (0%)	0 of 263 (0%)	0 of 263
Tampon CS	0 of 268 (0%)	0 of 268 (0%)	0 of 268

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Menstruation

Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
RecruitingPhase 4
Period Pills for Menstrual Regulation: A New Reproductive Health Option
Menstrual Regulation, Menstrual Health Intervention
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tampon BR, Tampon CR and Tampon BS in people with Menstruation, run by Kimberly-Clark Corporation at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Percentage of Used Tampons That Have Elongated (time frame: At the end of 1 menstrual period (up to 10 days) for each intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05553600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.